Anatomical Segmentectomies for Early Stage Lung Cancer. A Multicenter Analysis of RATS, VATS and Open Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 472
- 试验地点
- 4
- 主要终点
- The perioperative complications of robotic approach
研究概览
简要总结
The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.
详细描述
Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.
What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).
This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.
In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.
The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December
- •Age > then 18 years at the moment of surgery
排除标准
- •Age < then 18 years at the moment of surgery
- •diagnosis other than NSCLC
结局指标
主要结局
The perioperative complications of robotic approach
时间窗: from the surgery at 30-90 days after
The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
时间窗: 30-90 days after surgery
The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
The perioperative complications of the open approach
时间窗: 30-90 days after surgery
The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
次要结局
- Duration of surgery(up to 1 month)
- Quality of lymphadenectomy(up to 1 month)
- Conversion rate(up to 1 month)
- Survival analysis(up to 5 years)
研究者
Pierluigi Novellis
Principal Investigator
Scientific Institute San Raffaele